Matches in SemOpenAlex for { <https://semopenalex.org/work/W2008834703> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W2008834703 endingPage "287" @default.
- W2008834703 startingPage "278" @default.
- W2008834703 abstract "The aim of the study was to evaluate a lyophilized intravenous immunoglobulin (IVIG) preparation containing anti-D (02/228; nominal reciprocal titre of 8) for its suitability to define the maximum limit of anti-D in IVIG products when used in a proposed reference method of direct haemagglutination of papain-treated erythrocytes, in an international collaborative study.Twenty laboratories tested 02/228 along with a negative control IVIG preparation and four IVIG samples containing different levels of anti-D. Nineteen laboratories performed direct haemagglutination methodology using papain-treated erythrocytes; five of these laboratories and one additional laboratory performed their in-house haemagglutination methodology (all indirect antiglobulin tests).The mode titre of 02/228, obtained by using the proposed reference method, was 8 (62.5% of tests). However, there was wide variation in haemagglutination titres between laboratories for three of the four samples. Correcting the titres of the samples relative to those of the proposed reference preparation reduced the interlaboratory variability and increased the frequency of the mode titres in three out of four samples. The indirect antiglobulin tests also showed wide interlaboratory variability and were less sensitive than the direct method in four laboratories. Eleven of the 14 laboratories that expressed an opinion considered that the level of anti-D in 02/228 was appropriate to define a specified limit.Our results demonstrate the necessity of using a reference preparation to define the maximum level of anti-D in IVIG products and ensure sufficient sensitivity in haemagglutination testing methodology. On the basis of these results, members of the European Pharmacopoeia Expert Group 6B recommended revision of the appropriate monograph to include this new specification and test. The Food and Drug Administration in the USA intends to adopt the same maximal specification defined by the reference preparation and to recommend the same test for the safety of IVIG products. Preparations 02/228 and 02/226 were also established by the World Health Organization as International Reference Reagents to standardize haemagglutination testing for anti-D in normal IVIG products." @default.
- W2008834703 created "2016-06-24" @default.
- W2008834703 creator A5013830579 @default.
- W2008834703 creator A5029717167 @default.
- W2008834703 creator A5047338042 @default.
- W2008834703 creator A5051617624 @default.
- W2008834703 creator A5063567071 @default.
- W2008834703 creator A5077841485 @default.
- W2008834703 creator A5087476485 @default.
- W2008834703 date "2005-05-01" @default.
- W2008834703 modified "2023-10-10" @default.
- W2008834703 title "International collaborative study to evaluate a candidate reference preparation to define an appropriate specified limit of anti-D in intravenous immunoglobulin products" @default.
- W2008834703 cites W1965870997 @default.
- W2008834703 cites W1975913801 @default.
- W2008834703 cites W2030917541 @default.
- W2008834703 cites W2039188387 @default.
- W2008834703 cites W2072398164 @default.
- W2008834703 cites W4256251542 @default.
- W2008834703 doi "https://doi.org/10.1111/j.1423-0410.2005.00622.x" @default.
- W2008834703 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/15877651" @default.
- W2008834703 hasPublicationYear "2005" @default.
- W2008834703 type Work @default.
- W2008834703 sameAs 2008834703 @default.
- W2008834703 citedByCount "5" @default.
- W2008834703 countsByYear W20088347032015 @default.
- W2008834703 countsByYear W20088347032022 @default.
- W2008834703 crossrefType "journal-article" @default.
- W2008834703 hasAuthorship W2008834703A5013830579 @default.
- W2008834703 hasAuthorship W2008834703A5029717167 @default.
- W2008834703 hasAuthorship W2008834703A5047338042 @default.
- W2008834703 hasAuthorship W2008834703A5051617624 @default.
- W2008834703 hasAuthorship W2008834703A5063567071 @default.
- W2008834703 hasAuthorship W2008834703A5077841485 @default.
- W2008834703 hasAuthorship W2008834703A5087476485 @default.
- W2008834703 hasConcept C119128265 @default.
- W2008834703 hasConcept C159654299 @default.
- W2008834703 hasConcept C181199279 @default.
- W2008834703 hasConcept C185592680 @default.
- W2008834703 hasConcept C203014093 @default.
- W2008834703 hasConcept C2779832904 @default.
- W2008834703 hasConcept C2910284872 @default.
- W2008834703 hasConcept C32611913 @default.
- W2008834703 hasConcept C33923547 @default.
- W2008834703 hasConcept C34343649 @default.
- W2008834703 hasConcept C43617362 @default.
- W2008834703 hasConcept C45189115 @default.
- W2008834703 hasConcept C55493867 @default.
- W2008834703 hasConcept C71924100 @default.
- W2008834703 hasConceptScore W2008834703C119128265 @default.
- W2008834703 hasConceptScore W2008834703C159654299 @default.
- W2008834703 hasConceptScore W2008834703C181199279 @default.
- W2008834703 hasConceptScore W2008834703C185592680 @default.
- W2008834703 hasConceptScore W2008834703C203014093 @default.
- W2008834703 hasConceptScore W2008834703C2779832904 @default.
- W2008834703 hasConceptScore W2008834703C2910284872 @default.
- W2008834703 hasConceptScore W2008834703C32611913 @default.
- W2008834703 hasConceptScore W2008834703C33923547 @default.
- W2008834703 hasConceptScore W2008834703C34343649 @default.
- W2008834703 hasConceptScore W2008834703C43617362 @default.
- W2008834703 hasConceptScore W2008834703C45189115 @default.
- W2008834703 hasConceptScore W2008834703C55493867 @default.
- W2008834703 hasConceptScore W2008834703C71924100 @default.
- W2008834703 hasIssue "4" @default.
- W2008834703 hasLocation W20088347031 @default.
- W2008834703 hasLocation W20088347032 @default.
- W2008834703 hasOpenAccess W2008834703 @default.
- W2008834703 hasPrimaryLocation W20088347031 @default.
- W2008834703 hasRelatedWork W1965923698 @default.
- W2008834703 hasRelatedWork W2012061473 @default.
- W2008834703 hasRelatedWork W2359508004 @default.
- W2008834703 hasRelatedWork W2383721439 @default.
- W2008834703 hasRelatedWork W2461587430 @default.
- W2008834703 hasRelatedWork W259339301 @default.
- W2008834703 hasRelatedWork W37545621 @default.
- W2008834703 hasRelatedWork W4233337741 @default.
- W2008834703 hasRelatedWork W1222890113 @default.
- W2008834703 hasRelatedWork W2075484759 @default.
- W2008834703 hasVolume "88" @default.
- W2008834703 isParatext "false" @default.
- W2008834703 isRetracted "false" @default.
- W2008834703 magId "2008834703" @default.
- W2008834703 workType "article" @default.